Multi-institutional randomized controlled clinical trial on China made 4-demethoxydaunokrubicin (IDA) in the treatment of acute leukemia / 中华肿瘤杂志

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of IDA (Haizheng Parmacy, China) in the treatment of acute leukemia.</p><p><b>METHODS</b>A multi-institutional single-blind randomized controlled clinical trial was carried out. A total of 155 newly diagnosed patients with AML and ALL were enrolled. The patients were randomly divided into two groups, one was given IDA (n = 77) and the other given zevodas (Pharnacia & Upjohn, n = 78) for comparison.</p><p><b>RESULTS</b>All the patients enrolled in this trial were eligible for assessment of side effects, and 129 patients for evaluation of overall response rate. In patients treated with IDA vs zevodas, the overall response rate (OR) was 78.1% vs 76.9%, CR was 68.8% vs 67.7%; in AML patients, OR was 82.4% vs 71.8%, and CR was 76.5% vs 64.1%; in ALL patients, OR was 80.0% vs 81.8%, and CR was 68.0% vs 68.2%. There was no sitatistically significant difference in hematologic and non-hematologic toxicities between the two groups.</p><p><b>CONCLUSION</b>The efficacy of IDA in the treatment of acute leukemia is comparable to that of zevodas. Both have similar toxic side effects.</p>